The Clinical Evaluation Plan (CEP) is the document that defines the clinical evaluation strategy for a given device. Annex XIV, Part A of the MDR sets out its required content. It is the first document notified bodies ask for when they review a clinical file — even before the CER.
A CEP that fails to identify the device’s clinical gaps and does not define how they will be addressed is a merely formal document. Notified bodies spot it immediately.
The mandatory content under Annex XIV
Description and characterisation of the device. Intended purpose, target population, clinical indication, contraindications, device variants covered by the evaluation.
Specification of the relevant clinical data. Which clinical data are needed to demonstrate conformity with the applicable GSPR? Which safety and performance criteria must be documented? This section defines the expected level of evidence.
Plan for generating clinical data. How the data will be collected: systematic literature review, clinical investigations, post-market surveillance data, demonstration of equivalence. The strategy must be consistent with the device’s level of risk.
Reference to applicable standards and guidelines. MEDDEV 2.7/1 rev 4, ISO 14155 for clinical investigations, relevant MDCG guidelines.
PMCF plan. The post-market clinical follow-up activities planned to address the identified gaps and feed updates to the CER.
Frequency of CER updates. Justification of the chosen frequency based on the device’s class and risk profile.
What distinguishes a robust CEP from a merely formal one
A robust CEP identifies the device’s clinical gaps from the outset. It answers the question: “What do I not yet know about the safety and clinical performance of this device under real-world conditions of use?” These gaps are not an admission of weakness — they are unavoidable for any device that does not yet have a long clinical history. Notified bodies expect them to be identified honestly.
The correspondence between the gaps in the CEP and the content of the PMCF plan is the first consistency check notified bodies carry out. If the CEP identifies a lack of data on patients over 75, the PMCF must provide for specific data collection on this sub-population. If the link is missing, the reviewer raises it.
The most common mistake
Writing the CEP after the CER, in order to justify after the fact what has already been done. The CEP is meant to precede the CER and define its method. A CEP drafted after the event is often inconsistent with the CER, and notified bodies that read the two in order detect this without difficulty.